Introduction

As the landscape of therapeutic development rapidly evolves, so do the operating models that support it. The relationship between biotechs and Contract Development and Manufacturing Organizations (CDMOs) has fundamentally shifted—from transactional outsourcing arrangements to strategic co-execution frameworks. In an era marked by increased scientific complexity, shorter Funding cycles, and increased regulatory scrutiny, there is no room for misalignment.

Advanced modalities such as antibody-drug conjugates (ADCs), oligonucleotides, and mRNA-based therapies require seamless integration across analytical development, quality systems, regulatory readiness, and manufacturing execution. At the same time, policies like the BioSecure Act highlight the need for operational transparency, supply chain traceability, and mitigation of geopolitical risks.

Despite these changes, many collaborations between biotechs and CDMOs still face issues like unclear expectations, fragmented decision-making, and reactive project management. Biotechs often enter partnerships expecting faster results and greater flexibility, while CDMOs struggle to interpret vague scopes within tight timelines—leading to operational conflicts, missed milestones, and loss of trust.

To better understand how collaboration models can be improved, this commentary relies on structured input from multiple biotech and CDMO leaders across the industry. Their responses to a curated set of operational and scientific questions highlight key patterns in both failure and success.

Specifically, this panel discussion explores:

• How biotechs assess CDMO fit for complex modalities
• How CDMOs engage with limited early-phase data to de-risk scale-up
• What practices foster trust, alignment, and decision clarity
• And how both sides can shift from coordination to genuine co-execution

The goal is not to repeat familiar challenges, but to suggest a practical operating framework for CDMO–biotech partnership—one rooted in mutual accountability, scientific consistency, and behavioral unity. In a sector where the pace of innovation now depends on operational discipline, collaboration has become a key skill.

From Vendors to Velocity Partners: Reframing CDMO–Biotech Collaboration

The conventional construct of the CDMO–biotech relationship — a transactional outsourcing model centered on deliverables and timelines — is no longer tenable in today’s high-stakes, modality-driven development environment. The increasing complexity of drug candidates such as antibody-drug conjugates (ADCs), oligonucleotides, and RNA-based therapeutics, combined with compressed development cycles and evolving regulatory expectations, demands a new framework: strategic co-execution.

In this model, CDMOs are not external executors but integrated contributors — scientific, operational, and regulatory partners accountable for shared success. The transition from “vendor” to “velocity partner” is not semantic. It is a fundamental redefinition of how biotech companies must approach outsourcing if they are to accelerate development without compromising quality or compliance.

Moving Beyond Siloed Execution

Legacy engagement models — often driven by procurement timelines or minimal technical criteria — fail to anticipate the ambiguity and risk that define early- and mid-phase development. Under such conditions, misalignment between sponsor expectations and CDMO operations leads to common and costly issues: rework, scope creep, tech transfer delays, and strained regulatory interactions.

Conversely, high-functioning partnerships exhibit the following characteristics:

• Early-stage technical integration involving cross-functional input from chemical, finished dosage, analytical, quality, regulatory, and manufacturing teams.
• Bidirectional accountability, where both parties share responsibility for meeting milestones and managing risk.
• Operational transparency, backed by shared project governance and real-time data access
• Unified interpretation of priorities, particularly around speed, quality, and cost under constraint

These are essential attributes for ensuring reliable execution amidst the rising demands of fast-to-clinic programs, not just aspirational ideals.

Values as Decision Infrastructure

Building on our previous work on organizational coherence, it is clear that values are more than just soft concepts; they serve as practical decision-making frameworks. When timelines are tight and information is limited, what guides CDMO and biotech team behavior? Is there a shared understanding of what to prioritize, when to escalate issues, and how to interpret “client-centric” or “risk-based” approaches?

Many breakdowns stem not from capacity or capability gaps, but from behavioral misalignment under stress. A CDMO may view “flexibility” as last-minute rework; a biotech might see it as proactive problem-solving. Without a shared language and decision logic, trust diminishes.

Effective CDMO–biotech collaborations, therefore, require aligned principles, not just aligned timelines. These principles must be embedded into operating rhythms — kickoff templates, governance models, risk registers — and reinforced in moments of ambiguity.

From Tactical Execution to Strategic Orchestration

CDMOs that succeed in this new paradigm act as orchestration partners. They proactively anticipate downstream regulatory implications, incorporate phase-appropriate controls, and guide biotechs through uncertainties. This role requires scientific fluency, regulatory literacy, and behavioral maturity to share ownership effectively.

Biotechs, in turn, must shift from outsourcing activity to co-designing execution — embracing clarity, readiness, and communication as core enablers, not overhead. CDMO–biotech collaboration must evolve from a supplier-based relationship to a strategic execution model grounded in alignment, transparency, and mutual accountability. This evolution is not optional. It is the price of speed, and the currency of trust in a biotech landscape defined by complexity and consequence.

What Biotechs Must Get Right: Clarity as a Competitive Advantage

While much focus is on CDMO performance and technical skills, a collaboration’s success or failure often starts earlier—in how biotechs prepare, set, and manage their own expectations. From the feedback collected from CDMO leaders across the panel, a clear pattern appeared: inefficiencies in early phases and problems in later execution are often caused by a lack of clarity from the biotech sponsor.

Precision Begins with the RFP

The request for proposal (RFP) sets the tone for the partnership, yet many CDMOs report that biotech RFPs are often aspirational rather than actionable. Common gaps include:

• Unclear project scope
• Incomplete analytical or process characterization data.
• Misaligned timelines relative to technical complexity
• Omission of phase-appropriate regulatory context

A robust RFP should clearly articulate not only the “what” (deliverables) but also the “why” (clinical objective, development phase, regulatory intent) and the “how” (critical quality attributes, control strategy, and risk assumptions). When this level of specificity is missing, CDMOs are forced to make assumptions that may later require costly realignment.

Biotechs that invest time in refining their RFPs—ideally with cross-functional input from analytical, regulatory, and CMC teams—set a more realistic foundation for the work ahead.

Internal Readiness and the Role of the Project Manager

Another common obstacle to efficient execution is the lack of a dedicated internal project manager (PM) with adequate scientific knowledge and decision-making power. Without this role, communication between the biotech and CDMO becomes delayed or scattered, and critical issues are either escalated too late or not addressed consistently.

Sponsors should ensure that the internal PM:

• Has cross-functional visibility (analytical, quality, clinical, regulatory)
• Maintains continuity of communication with the CDMO’s lead team
• Has the authority to approve scope clarifications and contingency decisions

The internal PM is not merely a coordinator but a key enabler of technical alignment and real-time decision-making.

Minimizing Scope Creep through Defined Milestones

Scope creep is a persistent challenge in CDMO–biotech engagements. In many cases, this results not from intentional expansion but from insufficient initial planning or evolving sponsor expectations.

To mitigate this, biotechs should:

• Define clear go/no-go decision points tied to data generation.
• Establish predefined buffers for non-critical change requests.
• Incorporate change control protocols into the governance plan.

Project charters should explicitly list what is in scope, what is excluded, and how changes will be assessed from both technical and budgetary standpoints. CDMOs can only protect timelines if biotechs provide a stable scope of work supported by decision logic.

Building Tech Transfer Maturity

In early-phase collaborations, many biotechs struggle to assemble a complete and coherent technology transfer package. When methods are only partially qualified, or formulation data is preliminary, the burden of translation shifts to the CDMO—introducing risk, rework, and variability.

To improve transfer efficiency, biotech companies should:

• Use standardized tech transfer templates with predefined quality criteria.
• Provide method validation status and known method limitations.
• Include risk assessments with development history and troubleshooting insights.

Even when documentation is incomplete, transparency regarding the current state of knowledge allows CDMOs to plan development workstreams better and avoid duplication of effort.

Communication is a System, not a Meeting.

Finally, communication failure is rarely about frequency—it is about structure. Biotechs often rely on status meetings without a broader operating rhythm, leading to reactive behavior and decision paralysis.

Successful partnerships incorporate:

• Clear communication protocols with named points of contact
• Joint dashboards for real-time tracking of progress, deviations, and risks
• Phase-specific governance models that evolve with programming maturity

Sponsors must also ensure that internal escalation pathways are well-defined—so that urgent decisions do not get bottlenecked by indecision or lack of clarity about authority.

What CDMOs Must Do: Operating with Scientific Authority and Strategic Maturity

While much of the discussion about biotech–CDMO collaboration centers on sponsor readiness, CDMOs themselves must advance beyond just compliance and capacity rhetoric. In complex programs, especially those involving advanced modalities like ADCs, oligonucleotides, and high-potency APIs, scientific expertise alone is insufficient. CDMOs need to operate with strategic maturity—showing not only the ability to follow instructions but also the capacity to guide, anticipate, and co-create solutions in real time.

This section distills the expectations placed on CDMOs by biotech partners and outlines the institutional behaviors, systems, and capabilities required to meet them.

Engage Early with Scientific and Regulatory Perspectives

CDMOs that excel in complex programs consistently provide a technical voice early in discussions—during RFP review, feasibility assessment, and early protocol transfer. This scientific involvement is not just courtesy; it is a risk mitigation strategy.

Biotechs seek CDMO partners who can:

• Identify regulatory gaps or risks based on limited data packages.
• Translate early analytical signals into downstream manufacturing implications.
• Provide formulation or method development input aligned with the molecule’s lifecycle.

Failure to embed this perspective early results in downstream inefficiencies, scope renegotiation, or missed critical development windows.

Build Systems for Transparency and Traceability

In fast-moving collaborations, trust is built through data visibility and process traceability. CDMOs that rely on ad hoc updates, PDF-based communication, or siloed systems cannot meet modern expectations for responsiveness or control.

Leading CDMOs are now implementing:

• Real-time dashboards that provide shared access to batch progress, deviations, and documentation status
• Integrated LIMS and project portals that reduce redundancy and version conflicts
• Standardized tech transfer and method qualification templates accessible to both teams

These systems not only improve delivery fidelity but also create a digital thread that supports audit readiness and regulatory defensibility.

Balance Flexibility with Phase-Appropriate Compliance

Biotechs often face tight deadlines—driven by funding milestones, clinical schedules, or board expectations. CDMOs need to respond to these demands without sacrificing compliance or scientific quality.

The hallmark of a mature CDMO is its ability to say:

“Yes, we can move fast — and here is how we’ll do it without sacrificing control.”

This requires:

• Risk-based quality frameworks that adjust controls based on the development phase
• Predefined “fast-track” pathways that align CMC activities with regulatory strategy
• Scenario planning tools that identify bottlenecks before they occur

In this context, flexibility is not improvisation; it is disciplined agility, supported by structured decision logic.

Invest in Talent That Understands Modality Nuance

Complex modalities demand specialized scientific capabilities, including linker-payload chemistry, oligonucleotide synthesis, and conjugation platform development. More than equipment or SOPs, it is the depth and retention of scientific talent that defines a CDMO’s ability to manage risk, respond to ambiguity, and engage as a technical peer.

Best-in-class CDMOs demonstrate:

• Cross-trained scientists capable of integrating analytical, formulation, and process perspectives
• Structured onboarding and internal knowledge transfer mechanisms
• Visible career development pathways to retain niche talent in high-demand areas

The biotech sector is watching not just what CDMOs build — but who they build with.

Communicate Risk Proactively and Constructively

A repeated point of frustration from biotech leaders is the lack of transparent communication around timeline risks. Delays are often inevitable in development. What separates competent CDMOs from strategic partners is how and when they communicate with them.

Proactive CDMOs:

• Share impact assessments before the sponsor asks
• Escalate based on triggers tied to timeline or quality thresholds.
• Propose mitigation strategies collaboratively rather than defensively.

This approach not only protects trust but also improves decision speed and regulatory positioning.

Lead Lifecycle Thinking from the Outset

Many biotech programs face fragmented planning—where early-phase decisions lead to complications on a commercial scale. CDMOs that adopt a lifecycle-integrated approach help sponsors make better trade-offs early.

This includes:

• Guiding phase-appropriate method validation with scale-up in mind
• Aligning formulation choices with long-term manufacturability and stability
• Advising on regulatory documentation that enables future bridging

CDMO’s role is not merely to deliver units; it is to de-risk development across the whole product lifecycle.

The expectations for CDMOs have changed. Sponsors now want partners who can smoothly integrate into their development ecosystem, provide scientific insights, ensure strict compliance, and advance progress with foresight. Operating at this level demands more than just technical skills; it requires strategic insight, transparency driven by data, and consistent reliability, even under pressure.

In a market driven by scientific ambition and operational constraints, CDMOs that serve as strategic co-developers—rather than just service providers—are the ones that consistently deliver value and build trust.

Shared Mistakes, Shared Lessons: Where Collaboration Breaks Down — and Why

Despite good intentions, CDMO–biotech partnerships often break down—not because of a lack of scientific knowledge or tools, but due to repeated behavioral and strategic mistakes. Input from CDMO executives and biotech leaders shows that common failure patterns exist. These lessons highlight that successful partnerships are rarely ruined by technical issues alone, but by unseen problems in alignment, ownership, and communication.

Misaligned Definitions of Success

One of the most common points of breakdown is the absence of a shared understanding of what success looks like at each stage of the program. While biotechs may prioritize clinical milestone acceleration, CDMOs may interpret “success” as compliance with specifications and audit-readiness. Without explicitly aligned definitions—embedded in governance charters and decision matrices—project teams tend to work at cross purposes.

Success criteria should be co-authored, not assumed. This includes technical endpoints, timeline tolerance thresholds, risk posture, and escalation paths. Alignment at kickoff is insufficient; it must be reinforced at each phase gate.

Scope Creep Without Structured Change Management

Scope creep is inevitable in development programs, particularly as additional assays, formulation modifications, or regulatory clarifications surface mid-project. However, many biotech sponsors expect flexibility from CDMOs without formally renegotiating deliverables, timelines, or budgets. This results in internal CDMO strain, timeline erosion, and eventual confrontation.

Change is not the problem; unstructured change is. CDMO–biotech agreements should include predefined change control frameworks with agreed timelines for re-evaluation, decision triggers, and impact assessments.

Delayed Communication of Risks and Deviations

A critical error—reported frequently by both CDMOs and sponsors—is the tendency to delay difficult conversations. Whether it’s a deviation that might affect a batch disposition, a slipped method transfer, or resource constraints due to concurrent programs, silence or soft communication of risk breeds mistrust.

The threshold for escalation should not be urgent, but potential impact. High-performing partnerships implement project risk registers with shared access and clear ownership for real-time status updates.

Poor Translation Between Functions

Scientific rigor often breaks down at the interface of functions—most notably between analytical and process development, or between regulatory strategy and operations. Many CDMOs and biotechs still operate in siloed functional hierarchies, causing rework, inconsistent documentation, and last-minute regulatory compromises.

Function-specific excellence is necessary, but insufficient. What matters is functional integration, which can be supported through cross-functional working teams, co-authored protocols, and shared accountability for deliverables.

Underestimating Cultural Compatibility

Finally, several panelists emphasized that cultural fit—the willingness to share information openly, the tolerance for ambiguity, the mutual respect for timelines and quality expectations—is a leading indicator of project success. Technical capability is essential, but without shared operating norms, even well-resourced projects can become combative and inefficient.

Sponsors and CDMOs must assess cultural alignment early, not post-contract. This includes expectations on responsiveness, documentation discipline, decision-making speed, and feedback culture. Pilot projects or limited-scope trials can serve as valuable diagnostic tools before expanding the engagement.

The most damaging failures in CDMO–biotech relationships are not dramatic—they are cumulative. They stem from assumptions left unspoken, risks left unflagged, and decisions left ambiguous. These failures are avoidable. When both parties institutionalize clarity, build systems for joint accountability, and create space for early tension detection, collaboration becomes not just functional but scalable.

The Missing Layer: Leadership as Operating Infrastructure

Technical competence and communication frameworks, while essential, are not enough to ensure robust CDMO–biotech collaboration. What often distinguishes successful partnerships is not how well systems are designed, but how leadership behaviors shape decision-making, risk management, and accountability under stress.

In high-complexity programs—particularly those involving novel modalities or accelerated timelines—uncertainty is inevitable. The ability to navigate that uncertainty depends on leadership, not as a function of title, but as an operating system. This includes how teams align, how decisions are made when data is incomplete, and how conflict is resolved without escalation.

These capabilities cannot be outsourced. Nor can they remain siloed. They must be embedded across the interface of sponsor and CDMO teams.

Leadership by Capability, Not Org Chart

Traditional collaboration models assign decision-making power by organizational hierarchy—biotech sponsors lead strategy, CDMOs execute tasks. But complex development demands a more fluid, capability-based approach.

Cross-functional mosaics, not individual experts, lead successful programs. These teams integrate regulatory foresight, analytical depth, quality mindset, operational fluency, and scientific agility into every project phase.

Key leadership capabilities include:

• Strategic translation: ability to connect clinical or regulatory goals with CMC execution
• Technical fluency across functions: particularly at the intersection of process, analytical, and formulation science
• Scenario planning and ambiguity tolerance: to adapt proactively under compressed timelines or shifting scope
• Ownership mindset: regardless of company boundary, functional role, or reporting line

From Meetings to Operating Models

Too often, “collaboration” is reduced to regular meetings and status updates. But meetings do not build alignment—systems do.

Transformative partnerships implement:

• Joint governance councils blending sponsor and CDMO leads across regulatory, analytical, and manufacturing functions.
• Shared accountability structures with co-owned milestones and KPIs
• Transparent escalation paths that empower frontline teams to resolve issues rapidly
• Integrated OKRs (objectives and key results) that drive shared behavior, not parallel effort

This is not about adding layers of oversight, but replacing reactive communication with proactive coordination mechanisms that scale.

Culture Is a Leadership System

Culture—how people behave when decisions are complex—is not the job of HR. It is a reflection of what leaders reward, tolerate, and model.

High-trust collaborations emerge when:

• Teams feel safe surfacing risks before they escalate.
• Leaders model transparency rather than defensiveness
• Constructive dissent is encouraged and integrated into decision-making.
• Feedback loops are fast, non-punitive, and anchored in shared outcomes.

These traits are not aspirational; they are now prerequisites for operating at the speed and complexity required by today’s biotech programs.

AI, Automation, and Digital Fluency as Leadership Leverage

As CDMOs and biotechs expand their digital infrastructure, leadership must evolve to own the application of tools such as LIMS, collaborative portals, predictive risk modeling, and proposal automation—not merely delegate them to IT or operations.

Digital maturity in a collaborative setting requires:

• Understanding how AI can augment forecasting, scenario planning, and stability modeling
• Leveraging dashboards and shared systems for visibility and accountability
• Ensuring that data quality and decision logic remain intact as speed increases

The future of development execution is digital—but only if leadership systems are ready to translate that capability into value.

True collaboration is not built on Gantt charts or signed SOWs. It is built on shared leadership behaviors that drive scientific integration, operational agility, and decision clarity. The absence of this layer—despite technical proficiency—often explains why promising partnerships fail.

Redesigning Collaboration: A Co-Execution Framework

In a development environment defined by speed, complexity, and constrained resources, the traditional CDMO–biotech model—based on service-level agreements and technical deliverables—has reached its limits. What’s needed now is a co-execution framework: an operating model that enables two distinct organizations to function with shared clarity, joint accountability, and adaptive execution.

This section outlines the foundational components of strategic co-execution, translating insights from both sponsor and CDMO perspectives into practical structures that enhance scientific integration, operational discipline, and long-term scalability.

Joint Operating Rhythm

A hallmark of effective collaboration is not how often teams meet, but how consistently they act across functions and phases. Co-execution requires a structured operating rhythm that aligns both companies’ activities without redundancy.

Core elements include:

• Phase-specific governance models (e.g., discovery, pre-IND, post-Phase I)
• Shared kickoff frameworks including roles, risk maps, and escalation logic
• Integrated calendar of activities tied to joint milestones—not just internal deadlines

This structure reduces project drift and prevents late-stage surprises.

Co-Owned Technical Risk Register

Most development programs will encounter scientific ambiguity, shifting priorities, or unexpected assay behavior. What differentiates high-performing teams is the ability to identify, document, and manage risk collaboratively.

A shared risk register should:

• Capture scientific, regulatory, and operational risks in a standard format.
• Assign joint ownership and mitigation actions.
• Serve as a live document reviewed in governance meetings.

This approach normalizes complexity and moves teams from reaction to preparedness.

Bi-Directional KPIs and Incentive Alignment

Conventional CDMO performance metrics (e.g., on-time delivery, batch success rates) are necessary but insufficient. Sponsors also need insight into how work is executed—especially when timelines slip or scope evolves. Co-execution introduces bi-directional metrics, such as:

• Sponsor responsiveness and scope stability
• CDMO deviation resolution speed and communication clarity
• Joint adherence to change control timelines
• Shared success indicators (e.g., IND filing quality, audit readiness)

Including these metrics in QBRs and performance dashboards increases transparency and trust.

Digital Integration and Shared Systems

Co-execution is enabled by real-time, secure access to critical data. Many delays stem not from technical issues, but from fragmented systems and asynchronous communication.

Modern partnerships now employ:

• Shared dashboards (timeline, batch progression, document status)
• Collaborative document portals with version control
• Integrated LIMS access or tailored data exports for cross-validation

These tools reduce time lost to clarification, duplicate requests, and information silos.

Scenario Planning and Pre-Approved Contingencies

One of the most effective tools in complex program management is structured scenario planning. Teams that anticipate potential roadblocks—regulatory shifts, method delays, manufacturing constraints—are better equipped to respond without disruption.

Sponsors and CDMOs should jointly define:

• What-if scenarios across timeline, regulatory, and CMC variables
• Pre-approved contingency pathways (e.g., alternative assay validation strategies)
• Financial and timeline impacts for each scenario

This minimizes reactive decision-making and maintains project momentum.

Behavioral Expectations and Decision Logic

The final layer of co-execution is behavioral. Teams must agree on how decisions are made under ambiguity, especially when speed, quality, and cost collide.

Best practices include:

• Documented decision-making frameworks for scientific ambiguity or deviations
• Clarified roles for technical, regulatory, and quality sign-offs
• Expectations around escalation etiquette, issue framing, and feedback cycles

These norms prevent internal friction and enable productive disagreement—a critical trait in innovation-intensive environments.

Strategic co-execution is not a theory. It is an evolving framework that builds resilience, clarity, and speed into CDMO–biotech partnerships. By aligning technical governance, risk transparency, communication infrastructure, and shared behavioral norms, organizations can collaborate more like integrated teams than independent contractors.

Closing: The Partnership Litmus Test

In an industry where timelines are non-negotiable, innovation is high-risk, and regulatory scrutiny is intensifying, the difference between a successful drug development program and a failed one often comes down to how well two organizations work together under pressure.

What has become evident through this panel—and through two decades of hands-on development leadership—is that traditional sponsor–CDMO relationships, based on compliance, contract terms, and tactical coordination, are no longer sufficient. The future belongs to partnerships grounded in strategic co-execution: joint decision-making, shared behavioral norms, and integrated risk ownership. This shift is not just philosophical. It is operational, measurable, and increasingly essential.

The Litmus Test for Modern Collaboration

As both biotechs and CDMOs reflect on their current partnerships, a simple but revealing test can help evaluate maturity:

• When ambiguity arises, do both teams seek clarity—or seek cover?
• When timelines slip, do both sides adjust together—or escalate blame?
• When decisions are urgent, do both parties act with aligned judgment—or retreat into functional silos?
• And when success is achieved, is it viewed as mutual or one-sided?

If the answers to these questions expose hesitation, silos, or reactive behavior, then the partnership is not yet operating at its full potential.

The Real Differentiator Is Not Infrastructure — It’s Behavior

Many CDMOs today boast advanced instrumentation, expanded cleanroom space, and cross-site scalability. Likewise, many biotech firms bring cutting-edge science and promising therapeutic platforms. Yet execution still fails—not for lack of capacity or intellect, but for lack of behavioral alignment under stress.

What defines a high-performing collaboration is not the absence of problems, but the presence of:

• Clarity when priorities collide
• Transparency when risk emerges
• Shared logic when the data is incomplete
• And trust when speed and quality must coexist.

These are the traits that drive not only faster filings and more robust submissions—but also repeat business, team retention, and long-term credibility with regulators and investors alike.

Final Reflection

As complexity deepens and expectations rise, both CDMOs and biotechs face a shared imperative: to rethink how they partner — not just to deliver, but to learn, adapt, and succeed together.

Throughout this panel, leading biotech, CDMO executives shared candid insights from the frontlines — where ambitious science meets operational reality. What emerged wasn’t a single “right” model, but a recurring theme: alignment is everything.

The organizations that will define the next era of drug development won’t be those with the largest footprint or the fastest timelines. They’ll be the ones that master the art of thinking together, deciding together, and moving forward together — anchored in scientific discipline, operational clarity, and behavioral trust.

Because in today’s environment, execution is no longer the finish line.

It is the differentiator. Alignment is the new infrastructure.